2014 ISPE CMO Conference

Schedule-at-a-Glance

Wednesday, 4 June
07:00 - 08:00 Breakfast Session: Breakfast with the Inspectors
08:30 - 08:40 Drug Shortage: Opening Remarks
  • Leader: Thomas Cosgrove, JD, Acting Director, Office of Compliance, FDA/CDER/OC, USA
  • Leader: Joseph Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
08:40 - 09:40 Plenary Session with Q&A: Report of the ISPE Drug Shortages Task Force on Emerging Strategies for Preventing and Mitigating Shortages
  • Moderator: Joseph Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
  • Moderator: François Sallans, PharmD, VP Quality & Compliance, Chief Quality Officer, Johnson & Johnson, USA
    Keys to Addressing Drug Shortages
  • Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA, United Kingdom
    Drug Shortages - UK Response
  • Douglas Throckmorton, MD, Deputy Center Director for Regulatory Programs, FDA/CDER, USA
    FDA Response to Drug Shortages
09:40 - 10:40 ISPE Drug Shortage Updates
10:40 - 11:00 Networking Break
11:00 - 12:00 Industry-Regulatory Roundtable: Implications of the Finding sof the Drug Shortages Task Force
  • Moderator: Joseph Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
  • John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., United Kingdom
  • Thomas Cosgrove, JD, Acting Director, Office of Compliance, FDA/CDER/OC, USA
  • Sabine Haubenreisser, PhD, EMA-FDA Liason, FDA/OC/OGROP/OIP, USA
  • Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA, United Kingdom
  • Karen Hirshfield, RPh, Senior Compliance Specialist, Genentech-Member of Roche Group, USA
  • Larry Kranking, Vice President, International Consulting, Commissioning Agents, Inc., USA, Invited
  • François Sallans, PharmD, VP Quality & Compliance, Chief Quality Officer, Johnson & Johnson, USA
  • Douglas Throckmorton, MD, Deputy Center Director for Regulatory Programs, FDA/CDER, USA
  • Sumanth Venugopal, Partner, PricewaterhouseCoopers LLP, USA
  • Frances Zipp, President & CEO, Lachman Consultant Services, USA
12:00 - 13:00 Lunch
13:00 - 13:10 Welcome and Introduction - CMO Executive Workshop
13:10 - 13:40 Keynote Presentation
  • Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson, USA
    Industry Expectations and Challenges of Contracted Work
13:40 - 14:10 Keynote Presentation
  • Steve Leonard, Sr VP of Global Operations, Catalent Pharma Solutions, USA
    CMO Expectations and Challenges of Contracted Work
14:10 - 14:40 Keynote Presentation
  • Michael Levy, Senior Counsel, Compliance, FDA/CDER/OC, USA
    The Regulatory Expectations and Challenges of Contracted Work
14:40 - 15:00 Keynote Presentation
  • Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA, United Kingdom
    What makes Contracted Manufacture Successful?
15:00 - 15:15 Question and Answer Opportunity
15:15 - 15:30 Networking Break
15:30 - 17:30 WORKSHOP 1: The Selection Phase
  • Leader: Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson, USA
  • Facilitator: Michael Arnold, R.Ph., Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies, USA
  • Facilitator: Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Facilitator: Lisa Hawkins, Dir Regulatory & Agency Affairs, KeyTronicEMS, USA
  • Facilitator: Paula Katz, J.D., Supervisory Consumer Safety Officer, FDA, USA
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
  • Facilitator: George Millili, PhD, Senior Principal Technical Advisor, Genentech (A member of the Roche group), USA
  • Facilitator: Michael Smedley, Deputy Office Director of OPRO in OPQ, FDA/CDER/OPQ/OPRO, USA
Thursday, 5 June
08:00 - 10:00 WORKSHOP 2: The Start-Up Phase
  • Leader: Craig Kennedy, Sr. Vice President, Supply Chain Management, Merck & Co Inc, USA
  • Facilitator: Michael Arnold, R.Ph., Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies, USA
  • Facilitator: Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Facilitator: Lisa Hawkins, Dir Regulatory & Agency Affairs, KeyTronicEMS, USA
  • Facilitator: Paula Katz, J.D., Supervisory Consumer Safety Officer, FDA, USA
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
  • Facilitator: George Millili, PhD, Senior Principal Technical Advisor, Genentech (A member of the Roche group), USA
  • Facilitator: Michael Smedley, Deputy Office Director of OPRO in OPQ, FDA/CDER/OPQ/OPRO, USA
10:00 - 10:30 Networking Break
10:30 - 12:30 WORKSHOP 3: The Governance Process
  • Leader: Sridhar Krishnan, VP Global Operations, Catalent Pharma Solutions, USA
  • Facilitator: Michael Arnold, R.Ph., Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies, USA
  • Facilitator: Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Facilitator: Lisa Hawkins, Dir Regulatory & Agency Affairs, KeyTronicEMS, USA
  • Facilitator: Paula Katz, J.D., Supervisory Consumer Safety Officer, FDA, USA
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
  • Facilitator: George Millili, PhD, Senior Principal Technical Advisor, Genentech (A member of the Roche group), USA
  • Facilitator: Michael Smedley, Deputy Office Director of OPRO in OPQ, FDA/CDER/OPQ/OPRO, USA
12:30 - 13:30 Lunch
13:30 - 15:30 WORKSHOP 4: The Delivery Phase
  • Leader: Wesley Wheeler, CEO, Marken, LLP, USA
  • Facilitator: Michael Arnold, R.Ph., Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies, USA
  • Facilitator: Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
  • Facilitator: Lisa Hawkins, Dir Regulatory & Agency Affairs, KeyTronicEMS, USA
  • Facilitator: Paula Katz, J.D., Supervisory Consumer Safety Officer, FDA, USA
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
  • Facilitator: George Millili, PhD, Senior Principal Technical Advisor, Genentech (A member of the Roche group), USA
  • Facilitator: Michael Smedley, Deputy Office Director of OPRO in OPQ, FDA/CDER/OPQ/OPRO, USA
15:30 - 16:00 Networking Break
16:00 - 17:00 Debrief and Action Items from Workshops and Closing Remarks

Announcements:

MAKE SURE YOUR COMPANY'S VOICE IS HEARD!  

Discussions from the workshops will be collated for the development of a white paper to inform the development of guidance on this topic.

Featured KEYNOTE Speakers

Michael Levy, Senior Counsel, Compliance, FDA/CDER/OC

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions

Thank you to our PROGRAM COMMITTEE!

Tim Tyson, Chairman and CEO, Aptuit, Inc. – Chair

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions – Co-Chair

Paula Katz, J.D, Acting Branch Chief, Regulatory Policy and Collaboration, FDA/OMPQ - Co-Chair

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson - Co Chair

Joachim Del Boca, Apotheker, Vetter Pharma-Fertigung GmbH & Co KG

Mike Arnold, Senior. Director, Strategic Partnerships, Investigational Products, Pfizer Global Clinical Supplies

Lisa Hawkins, Consultant, Commissioning Agents, Inc.